Roles and Responsibilities:

1. Experience in QC activities i.e. Analysis of API (Wet and instrument)

2. Calibration of critical analytical instrument i.e. HPLC, GC. ICP-OES,IC, AAS, LC-MS, Stability Chamber etc.

3. Experience in method validation e.g. in related substance, assay content, elemental impurities as per regulatory guideline (ICH)

4. Experience in preparation, reviewal and approval QC document i.e. specification, test method, analytical test report, stability study report and method validation report.

5. Knowledge of General chapter requirement as per monograph. E.g. USP, BP,EP, IP

6. Knowledge of review and approval of computer system validation report of analytical instrument as per 21 CFR Part II requirement or GAMP5 requirement.

7. Experience in reviewing and approval of QMS document related to QC i.e. OOS, OOT, Change control, Deviation, Laboratory incident.

8. Experience in reviewing and approval of analytical instrument audit trail as applicable. (HPLC, GC, ICP-OES,IC, AAS. LC-MS)

9. Experience in handling of customer audit and expose to regulatory audit will be preparable.